# K161839: 2D Quantitative Analysis

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jul 29, 2016 after 24 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K801623 (1980). 53 ancestors in all.
No later device cites it as a predicate yet.
1 of 54 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141979: Allura Xper FD Series / Allura Xper or Table Series, Philips Medical Systems Netherland BV (2014) Summary page 4.

## Indications for use
2D Quantitative Analysis is a post processing software medical device intended to assist physicians through providing quantitative information as additional input for their comprehensive diagnosis decision making process and planning during cardiovascular procedures and for post procedural evaluation. 2D Quantitative Analysis consists of six applications: The 2D Quantitative Coronary Analysis application is intended to be used for quantification of coronary artery dimensions (approximately 1 to 6 mm) from 2D angiographic images. The 2D Quantitative Vascular Analysis application is intended to be used for quantification of aortic and peripheral artery dimensions (approximately 5 to 50 mm) from 2D angiographic images. The 2D Left Ventricle Analysis and the Biplane 2D Left Ventricle Analysis applications are intended to be used for quantification of left ventricular volumes and local wall motion from monoplane and from biplane angiographic series, respectively. The 2D Right Ventricle Analysis and the Biplane 2D Right Ventricle Analysis applications are intended to be used for quantification of right ventricular volumes and local wall motion from monoplane and from biplane angiographic series, respectively.

Source page: https://510kreport.com/device/K161839
Methodology: https://510kreport.com/methodology